Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02894684
• Date of registration: 01/09/2016
• Prospective Registration: Yes
• Primary sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Public title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis AZTEC-CF
• Scientific title: Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
• Date of first enrolment: January 2017
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02894684
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Freddy Frost, BMBS BMedSci
• Affiliation: Liverpool Heart & Chest Hospital NHS Foundation Trust

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Confirmed diagnosis of CF

2. Patients aged 18 - 65 years of age who can give informed consent

3. FEV1 >25% or <75% predicted (in keeping with Cayston® license)

4. Admitted to the Liverpool Heart & Chest Hospital with an exacerbation of CF pulmonary
disease

5. Presence of PA in lower respiratory tract cultures in the 6 months prior

Exclusion Criteria:

1. Documented allergy to beta-lactam antibiotics or IV Colistin

2. Growth of Burkholderia Cepacia Complex (BCC) within 2 years

3. Pregnancy

4. Previous organ transplant

5. Receiving other clinical trial medication

6. Already prescribed regular Cayston®



Age minimum: 16 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Infection

Pseudomonas

Cystic Fibrosis

Intervention(s)

Drug: Aztreonam

Drug: Standard Care

Primary Outcome(s)

Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 [Time Frame: 14 days]

Secondary Outcome(s)

PA sputum counts [Time Frame: 14 days]

Average change from baseline in the Cystic Fibrosis Quality of Life Questionnaire (CFQ-R) [Time Frame: 14 days]

Antimicrobial resistance [Time Frame: 14 days]

Microbiome changes [Time Frame: 14 days]

Time to first pulmonary exacerbation [Time Frame: 12 months]

Secondary ID(s)

2016AZLIND001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Liverpool